Current Environment:

Summary

It is difficult to assess pain and agitation in the NICU population because for a multitude of reasons including the pre-verbal nature of the patient population, the atypical pain response of premature infants, and the use of muscle relaxing medications that exclude motor response in pain assessments. Current assessment tools are based on physical exam and vital signs. The investigators propose to study the role of EEG and palmar conductance (PD) as additional tools in the assessment of pain and agitation

Conditions

Pain, Postoperative

Recruitment Status

Recruiting

Detailed Description

This is a prospective, non-interventional study designed to assess noxious-specific neurophysiologic responses and clinical signs following procedural pain in infants requiring hospitalization in the neonatal intensive care unit (NICU) following elective surgery. The main goal of the study is to develop a method that reliably quantifies the level of pain induced from clinically-required noxious procedures to infants hospitalized in the NICU. This method will use measures of neurophysiological, autonomic, and behavioral responses to non-noxious and clinically-required noxious stimuli in order to guide the pharmacological treatment of NICU patients with analgesic agents, sedatives and/or muscle relaxants. The investigators hypothesize that resting state activity and physiological responses to noxious and non-noxious stimuli provide a more reliable assessment of the level of pain of infants hospitalized in the NICU compared to behavioral-based pain scores.

Eligibility Criteria

Inclusion Criteria:

All patients will be admitted to the NICU, and having a post-menstrual age of >28 weeks. Participants will be divided into four groups according to the following criteria:

Group A

Plan for major surgery anticipated to cause pain and agitation (i.e. esophageal atresia treatment);
Patients who are anticipated to receive prolonged post-surgical neuromuscular blockade

Group B

Plan for major surgery anticipated to cause pain and agitation (i.e. bowel surgery);
Patients who are not anticipated to receive acute post-surgical neuromuscular blockade

Group C Plan for minor surgery anticipated to cause pain and agitation (i.e. hernia repair);

Group D No plan for surgery

Exclusion Criteria:

Confirmed or suspected clinical seizures
Metabolic abnormalities or inborn error of metabolism
Skin abrasions or wounds located at the site of research sensor placement i.e. scalp, which interfere with the application of electrodes

Intervention

Intervention Type

Intervention Name

Device

Waveguard (TM) EEG cap

Device

Micro Movement Sensor

Device

Pico Movement Sensor

Device

QS Piezostimulator

Device

tactileTM sensory evaluator

Gender

All

Minimum Age

N/A

Maximum Age

6 Months

Download Date

May 20, 2021

Principal Investigator

Laura Cornelissen PhD

Primary Contact Information

Laura Cornelissen, PhD

617-919-4641

laura.cornelissen@childrens.harvard.edu

Rachel Bernier, MPH

857-218-5348

rachel.bernier@childrens.harvard.edu

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: